USCDI Export for the Public

Unique, disambiguating identifier components for Organization-related elements. e.g. Provenance, identifier.assigner, and other elements and components that rely upon Organizations, especially those that may not be provider organizations nor have a URL. USCDI may need to support (or even consider requiring) organization.identifier.system to improve data portability. The parent way of identifying the system that enumerates multiple Organization identifiers may best be modeled as Organization.identifier.system, where the identifier uses existing FHIR properties for Identifiers data type. These include: identifier.system (URI namepsace) identifier.assigner (itself an organization!) identifier.value (a unique value)

For organizations like payers and ACOs, while health plan ID is no longer being pursued by industry, existing, in-production Payer IDs exist in multiple EDI (Electronic Data Interchange) environments. There are a set of Payer IDs in use today already; in concert with a clear description of the system that enumerates the Payer ID, these can be an example of the standards that may be used in uniquely identifying organizations beyond a free-text string description/label. These IDs may, however, be proprietary, but also already permissioned for use by the trading partners of the entities using the IDs for treatment, payment, and health care operations.

The date and time at which the EHR system sends the report.

A record of the patient’s authorizations and directions regarding disclosure and use of the patient’s SDOH data.

Yes, structural standards exist for each of these six elements in current HL7 standards. Specifically, in FHIR, (1) Assessments are Observation resources; (2) Problems/Health Concerns are Condition resources; (3) Goals are Goal resources; (4) Interventions are ServiceRequest and Procedure resources; (5) Outcomes are represented by the status on any of the previously mentioned resources or creation of new Observation resources; and (6) Consent is represented by the Consent resource. Yes, a vocabulary/terminology standard and/or technical specification exists for each proposed data element. The technical specifications for value sets under each data element are described below: • Assessments: LOINC • Health Concerns/Problems/Diagnoses: SNOMED-CT, ICD-10-CM • Goals: LOINC • Procedures/Interventions: SNOMED-CT (clinical), CPT/HCPCS (billing) • Outcomes: LOINC (NCQA measures) • Consent (where needed): based on existing HL7 code systems For the respective SDOH domains: For (1) Food Insecurity: LOINC, SNOMED-CT, ICD-10-CM, and CPT/HCPCS terminologies are specified by value sets in NLM’s Value Set Authority Center (VSAC). For (2) Housing Instability and Homelessness, (3) Inadequate Housing, (4) Transportation Insecurity, (5) Financial Strain, (6) Social Isolation, (7) Stress, (8) Interpersonal Violence, (9) Education, (10) Employment, and (11) Veteran Status: • The corresponding value sets are under development by the Gravity Project. • The value sets will be complete prior to publishing of USCDI v2.0; • Even if a particular value set might be incomplete, the value set will be citable. The details of the domains and specific consensus-approved value sets for each of the activities will be externally maintained as part of a hierarchy of LOINC panels and, where necessary, VSAC value sets referenced by the LOINC panels. The proposed structure is as follows: Survey (Panel) LOINC code a. Food Insecurity Domain (Panel) (LOINC code) i. Food Insecurity Assessment (Panel) (LOINC code) 1. Value set (LOINC codes) ii. Food Insecurity Health Concerns (Panel) (LOINC code) 1. Value set (SNOMED-CT and ICD-10-CM) iii. Food Insecurity Goals (Panel) (LOINC code) 1. Value set (LOINC codes) iv. Food Insecurity Interventions (Panel) (LOINC code) 1. Value set (SNOMED-CT, HCPCS, CPT, LOINC) v. Food Insecurity Outcomes (Panel) (LOINC code) 1. Value set (LOINC codes) b. Domain: Housing Instability and Homelessness c. Etc.

A clinical trial protocol is a detailed document that outlines the objectives, design, and methodology of a trial, ensuring consistency and regulatory compliance. It includes the study rationale, participant eligibility criteria, interventions, outcomes, randomization and blinding methods, procedures for data collection, safety monitoring, and adverse event reporting. The protocol also addresses data management, ethical considerations, and trial administration, providing a comprehensive framework for conducting the study.

For a clinical trial protocol, the following terminology code systems are commonly used or may be used for greater interoperability:

1. SNOMED CT: Standardizes clinical concepts like medical conditions, procedures, and outcomes (e.g., inclusion/exclusion criteria).
2. LOINC: Standardizes lab tests, clinical measurements, and observations collected during the trial.
3. RxNorm: Used for medication coding, especially when the protocol involves drug interventions or dosing regimens.
4. ICD-10/ICD-11: Defines diagnoses and health conditions for eligibility or adverse event reporting.
5. MedDRA: Used to code adverse events, ensuring consistent reporting across trial sites.
6. CDISC Terminology: Supports standardization of clinical trial data elements (e.g., protocol design, trial outcomes) in regulatory submissions. Accessible via NCI terminology services.
7. WHODrug: Standardizes coding for medications in clinical trials, especially for drug safety and efficacy reporting in global trials.
8. NDC: Used to identify medications in the U.S. for protocol interventions or treatments.
9. CPT: Standardizes medical procedures and services for protocol-specified interventions, such as diagnostic tests or treatments.
10. UCUM: Standardizes units of measurement (e.g., mg, mL) used in clinical observations or lab results.
11. HCPCS: Complements CPT by coding medical products, services, and equipment used in U.S. trials.

These code systems ensure global semantic interoperability, consistency, compliance, and accuracy in clinical trial data collection and exchange.

The postpartum status of a patient, i.e. whether or not the patient is in the postpartum perio

Value Set: Estimated Date of Delivery Including Method (https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.11.20.9.81/expansion)
Value Set: Pregnancy Status Determination Method (https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.11.20.9.80/expansion)
Postpartum Status (https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.11.20.9.87/expansion)

Name of the job position held by an individual.

Method for estimating gestational age, e.g., ultrasound, date of LMP.

Value Set: Estimated Date of Delivery Including Method (https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.11.20.9.81/expansion)
Value Set: Pregnancy Status Determination Method (https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.11.20.9.80/expansion)
Postpartum Status (https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.11.20.9.87/expansion)

The AJCC Cancer Staging System describes the severity of an individual's cancer based on the magnitude of the original (primary) tumor as well as on the extent cancer has spread in the body. Understanding the stage of the cancer helps doctors to develop a prognosis and design a treatment plan for individual patients. The AJCC Cancer Staging System classifies cancers by the size and extent of the primary tumor (T), involvement of regional lymph nodes (N), and the presence or absence of distant metastases (M), supplemented in recent years by evidence-based prognostic and predictive factors. There is a T,N,M staging algorithm for cancers of virtually every anatomic site and histology, with the primary exception of pediatric cancers. The three categories—T, N, and M—and the prognostic factors collectively describe, with rare exceptions, the extent of tumor, including local spread, regional nodal involvement, and distant metastasis. It is important to stress that each component (T, N, and M) is referred to as a Category. The term stage is used when T, N, and M and cancer site–specific required prognostic factors are combined. The Criteria for T, N, and M are defined separately for cancers in different anatomic locations and/or for different histologic types.

SNOMED CT has content related to the AJCC T category under the hierarchy of 385356007 'Tumor stage finding' but it is outdated and inaccurate. SNOMED CT codes do not always make a distinction between clinical and pathological classifications (e.g. cT1 and pT1) and are represented by the same SNOMED CT code 23351008 'T1 category'). SNOMED CT does not have complete T,N,M staging terminology and is an incomplete data set. Most importantly, the SNOMED structure is not a good fit for the AJCC data elements that can change as new editions/versions of the AJCC Cancer Staging System are published. However, the AJCC is planning on submitting the data elements to the National Library of Medicine’s Value Set Authority Center (VSAC), in parallel to the submission to USCDI. The AJCC feels that VSAC would be an appropriate centralized repository for AJCC data elements. This would facilitate EHR systems' use of the data elements that the AJCC develops and maintains.

For both Clinical (cT), Pathological (pT) and Neoadjuvant (ycT or ypT), the T Category is defined as the size and/or contiguous extension of the primary tumor. Note: The roles of the size component and the extent of contiguous spread are specifically defined for each cancer site. Primary Tumor (T) Categories: Primary tumor categories have specific notations to describe the existence, size, or extent of the tumor. TX: No information about the T category for the primary tumor, or it is unknown or cannot be assessed T0: No evidence of a primary tumor Tis: Carcinoma in situ T1, T2, T3, or T4: Primary invasive tumor, for which a higher category generally means • an increasing size • an increasing local extension, or • both

SNOMED CT has content related to the AJCC T category under the hierarchy of 385356007 'Tumor stage finding' but it is outdated and inaccurate. SNOMED CT codes do not always make a distinction between clinical and pathological classifications (e.g. cT1 and pT1) and are represented by the same SNOMED CT code 23351008 'T1 category'). SNOMED CT does not have complete T,N,M staging terminology and is an incomplete data set. Most importantly, the SNOMED structure is not a good fit for the AJCC data elements that can change as new editions/versions of the AJCC Cancer Staging System are published. However, the AJCC is planning on submitting the data elements to the National Library of Medicine’s Value Set Authority Center (VSAC), in parallel to the submission to USCDI. The AJCC feels that VSAC would be an appropriate centralized repository for AJCC data elements. This would facilitate EHR systems' use of the data elements that the AJCC develops and maintains.

A condition in which one is unable to regularly move from place to place in a safe and timely manner because one lacks the material, economic or social resources necessary for transportation. (Alix Gould-Werth, Jamie Griffin & Alexandra K. Murphy, “Developing a New Measure of Transportation Insecurity: An Exploratory Factor Analysis,” 11(2) Survey Practice , p. 1 (2018).) Currently under consideration by and in process with the Gravity community.

Yes, a vocabulary/terminology standard and/or technical specification exists for each proposed data element. The Gravity Project attaches a letter with an overview. For (1) Food Insecurity: LOINC, SNOMED-CT, ICD-10-CM, and CPT/HCPCS terminologies are specified by value set in NLM’s Value Set Authority Center (VSAC). For (2) Housing Instability and Homelessness, (3) Inadequate Housing, (4) Transportation Insecurity, (5), Financial Strain, (6) Social Isolation, (7) Stress, (8) Interpersonal Violence, (9) Education, (10) Employment, and (11) Veteran Status: • The corresponding value sets are under development by the Gravity Project; • The value sets will be complete prior to publishing of USCDI v2.0; • Even if a particular value set might be incomplete, the value set will be citable. The technical specifications for value sets under each data element are described below: • Assessments: LOINC • Health Concerns/Problems/Diagnoses: SNOMED-CT, ICD-10-CM • Goals: LOINC • Procedures/Interventions: SNOMED-CT (clinical), CPT/HCPCS (billing) • Outcomes: LOINC (NCQA measures) • Consent (where needed): based on existing HL7 code systems

Use of the tobacco plant leaf or its products. The predominant use of tobacco is by smoke inhalation of cigarettes, pipes, and cigars. Smokeless tobacco refers to a variety of tobacco products that are either sniffed, sucked, or chewed. An electronic cigarette is a vaporizer device that simulates smoking by providing some of the aspects of smoking that includes nicotine but without combusting tobacco. These products include psychoactive ingredient, nicotine. Question Prompt: Any use of tobacco (or nicotine-containing) products? Permissible Values: o Never (SNOMED: 702979003) An individual who has never consumed tobacco products in their lifetime. o Former (SNOMED: 702975009) An individual who has consumed tobacco products in his or her lifetime but who had quit consumption at the time of question. o Current - Daily (SNOMED: TBD) An individual who has consumed tobacco products in his or her lifetime, and who does so every day. o Current - Occasionally (SNOMED: TBD) An individual who has consumed tobacco products in his or her lifetime, who uses now, but does not use every day. o Unknown (SNOMED: TBD) An individual for whose tobacco product use is unknown.

There are SNOMED and LOINC Codes for most of the data elements but new codes will be requested for eCigarette use.

In the past year, have you spent more than 2 nights in a row in a jail, prison, detention center, or juvenile correctional facility? ☐ Yes ☐ No ☐ I choose not to answer this question

Z56.0 Conviction in civil and criminal proceedings without imprisonment Z65.1 Imprisonment and other incarcerations SNOMED: (Include children concepts) 365565007 - Finding of legal affairs and legal constraints (finding) LOINC: 93025-5 - Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences [PRAPARE]

Uncertain, limited, or unstable access to food that is: adequate in quantity and in nutritional quality; culturally acceptable; safe and acquired in socially acceptable ways. (Gravity Project.)

Yes, a vocabulary/terminology standard and/or technical specification exists for each proposed data element. The Gravity Project attaches a letter with an overview. For (1) Food Insecurity: LOINC, SNOMED-CT, ICD-10-CM, and CPT/HCPCS terminologies are specified by value set in NLM’s Value Set Authority Center (VSAC). For (2) Housing Instability and Homelessness, (3) Inadequate Housing, (4) Transportation Insecurity, (5), Financial Strain, (6) Social Isolation, (7) Stress, (8) Interpersonal Violence, (9) Education, (10) Employment, and (11) Veteran Status: • The corresponding value sets are under development by the Gravity Project; • The value sets will be complete prior to publishing of USCDI v2.0; • Even if a particular value set might be incomplete, the value set will be citable. The technical specifications for value sets under each data element are described below: • Assessments: LOINC • Health Concerns/Problems/Diagnoses: SNOMED-CT, ICD-10-CM • Goals: LOINC • Procedures/Interventions: SNOMED-CT (clinical), CPT/HCPCS (billing) • Outcomes: LOINC (NCQA measures) • Consent (where needed): based on existing HL7 code systems

Currently consistently housed, but experiencing any of the following circumstances in the past 12 months: being behind on rent or mortgage, multiple moves, homelessness; or currently living in a shelter, motel, temporary or transitional living situation, scattered site housing, or not having a consistent place to sleep at night; or lacking a fixed, regular, and adequate nighttime residence. (Richard Sheward, Allison Bovell-Ammon, Nayab Ahmad, Genevieve Preer, Stephanie Ettinger de Cuba & Megan Sandel, Promoting Caregiver and Child Health Through Housing Stability Screening in Clinical Settings, 39 Zero to Three J. 52, 52-53 (Mar. 2019); Megan Sandel, Richard Sheward, Stephanie Ettinger de Cuba, Sharon M. Coleman, Deborah A. Frank, Mariana Chilton, Maureen Black, Timothy Heeren, Justin Pasquariello, Patrick Casey, Eduardo Ochoa & Diana Cutts, Unstable Housing and Caregiver and Child Health in Renter Families, 141 Pediatrics e20172199, p. 3 (2018); McKinney-Vento Homeless Assistance Act of 1987, Pub. L. 100-77, § 103(a)(1), 101 Stat. 482, 485 (July 22, 1987).) Currently under consideration by and in process with the Gravity community.

Yes, a vocabulary/terminology standard and/or technical specification exists for each proposed data element. The Gravity Project attaches a letter with an overview. For (1) Food Insecurity: LOINC, SNOMED-CT, ICD-10-CM, and CPT/HCPCS terminologies are specified by value set in NLM’s Value Set Authority Center (VSAC). For (2) Housing Instability and Homelessness, (3) Inadequate Housing, (4) Transportation Insecurity, (5), Financial Strain, (6) Social Isolation, (7) Stress, (8) Interpersonal Violence, (9) Education, (10) Employment, and (11) Veteran Status: • The corresponding value sets are under development by the Gravity Project; • The value sets will be complete prior to publishing of USCDI v2.0; • Even if a particular value set might be incomplete, the value set will be citable. The technical specifications for value sets under each data element are described below: • Assessments: LOINC • Health Concerns/Problems/Diagnoses: SNOMED-CT, ICD-10-CM • Goals: LOINC • Procedures/Interventions: SNOMED-CT (clinical), CPT/HCPCS (billing) • Outcomes: LOINC (NCQA measures) • Consent (where needed): based on existing HL7 code systems

Codification of the type of medication list (e.g. Active medication list, Reconciled medication list, Discharged medication list, Discontinued (Inactive) medication list, Patient generated medication list (Different nuance, needs to be reviewed by a clinician before it can be entered as an active medication list), Medications that are private and need patient consent to share, Medication administration list, Medication administration list for public health and CDC reporting (e.g., for COVID, Antibiotics for Antibiotic Stewardship), Discharged medication list (Feeds the discharge summary that contains the Discharged medication list and when transferring within a hospital from one level of care to another (intersystem), a transfer medication list is used for MR).

LOINC

Housing with moderate to severe physical problems. ( U.S. Department of Housing and Urban Development, American Housing Survey: Housing Adequacy and Quality As Measured by the AHS, p. 2 (Mar. 2013).) Currently under consideration by and in process with the Gravity community.

Yes, a vocabulary/terminology standard and/or technical specification exists for each proposed data element. The Gravity Project attaches a letter with an overview. For (1) Food Insecurity: LOINC, SNOMED-CT, ICD-10-CM, and CPT/HCPCS terminologies are specified by value set in NLM’s Value Set Authority Center (VSAC). For (2) Housing Instability and Homelessness, (3) Inadequate Housing, (4) Transportation Insecurity, (5), Financial Strain, (6) Social Isolation, (7) Stress, (8) Interpersonal Violence, (9) Education, (10) Employment, and (11) Veteran Status: • The corresponding value sets are under development by the Gravity Project; • The value sets will be complete prior to publishing of USCDI v2.0; • Even if a particular value set might be incomplete, the value set will be citable. The technical specifications for value sets under each data element are described below: • Assessments: LOINC • Health Concerns/Problems/Diagnoses: SNOMED-CT, ICD-10-CM • Goals: LOINC • Procedures/Interventions: SNOMED-CT (clinical), CPT/HCPCS (billing) • Outcomes: LOINC (NCQA measures) • Consent (where needed): based on existing HL7 code systems

The knowledge and skills gained through education, the credentialing linked to the completion of various levels of schooling, and the quality of education. (Institute of Medicine, Capturing Social and Behavioral Domains in Electronic Health Records, Phase 2, p. 68 (2014).)

Yes, a vocabulary/terminology standard and/or technical specification exists for each proposed data element. The Gravity Project attaches a letter with an overview. For (1) Food Insecurity: LOINC, SNOMED-CT, ICD-10-CM, and CPT/HCPCS terminologies are specified by value set in NLM’s Value Set Authority Center (VSAC). For (2) Housing Instability and Homelessness, (3) Inadequate Housing, (4) Transportation Insecurity, (5), Financial Strain, (6) Social Isolation, (7) Stress, (8) Interpersonal Violence, (9) Education, (10) Employment, and (11) Veteran Status: • The corresponding value sets are under development by the Gravity Project; • The value sets will be complete prior to publishing of USCDI v2.0; • Even if a particular value set might be incomplete, the value set will be citable. The technical specifications for value sets under each data element are described below: • Assessments: LOINC • Health Concerns/Problems/Diagnoses: SNOMED-CT, ICD-10-CM • Goals: LOINC • Procedures/Interventions: SNOMED-CT (clinical), CPT/HCPCS (billing) • Outcomes: LOINC (NCQA measures) • Consent (where needed): based on existing HL7 code systems

Violence between individuals, subdivided into family and intimate partner violence and community violence. (World Health Organization, World Report on Violence and Health, p. 6 (2002).)

Yes, a vocabulary/terminology standard and/or technical specification exists for each proposed data element. The Gravity Project attaches a letter with an overview. For (1) Food Insecurity: LOINC, SNOMED-CT, ICD-10-CM, and CPT/HCPCS terminologies are specified by value set in NLM’s Value Set Authority Center (VSAC). For (2) Housing Instability and Homelessness, (3) Inadequate Housing, (4) Transportation Insecurity, (5), Financial Strain, (6) Social Isolation, (7) Stress, (8) Interpersonal Violence, (9) Education, (10) Employment, and (11) Veteran Status: • The corresponding value sets are under development by the Gravity Project; • The value sets will be complete prior to publishing of USCDI v2.0; • Even if a particular value set might be incomplete, the value set will be citable. The technical specifications for value sets under each data element are described below: • Assessments: LOINC • Health Concerns/Problems/Diagnoses: SNOMED-CT, ICD-10-CM • Goals: LOINC • Procedures/Interventions: SNOMED-CT (clinical), CPT/HCPCS (billing) • Outcomes: LOINC (NCQA measures) • Consent (where needed): based on existing HL7 code systems

A subjective state that arises when an individual recognizes a situation as threatening, but dealing with the threat requires more resources than the individual has available. (Institute of Medicine, Capturing Social and Behavioral Domains in Electronic Health Records, Phase 2, p. 76 (2014).)

Yes, a vocabulary/terminology standard and/or technical specification exists for each proposed data element. The Gravity Project attaches a letter with an overview. For (1) Food Insecurity: LOINC, SNOMED-CT, ICD-10-CM, and CPT/HCPCS terminologies are specified by value set in NLM’s Value Set Authority Center (VSAC). For (2) Housing Instability and Homelessness, (3) Inadequate Housing, (4) Transportation Insecurity, (5), Financial Strain, (6) Social Isolation, (7) Stress, (8) Interpersonal Violence, (9) Education, (10) Employment, and (11) Veteran Status: • The corresponding value sets are under development by the Gravity Project; • The value sets will be complete prior to publishing of USCDI v2.0; • Even if a particular value set might be incomplete, the value set will be citable. The technical specifications for value sets under each data element are described below: • Assessments: LOINC • Health Concerns/Problems/Diagnoses: SNOMED-CT, ICD-10-CM • Goals: LOINC • Procedures/Interventions: SNOMED-CT (clinical), CPT/HCPCS (billing) • Outcomes: LOINC (NCQA measures) • Consent (where needed): based on existing HL7 code systems

Unique identifier for a healthcare organization (i.e. CCN, NPI)

Unique identifiers for organizations/providers are assigned and governed uniformly. NPI: https://nppes.cms.hhs.gov/#/ CCN: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R29SOMA.pdf Clinical Laboratory Improvement Amendments (CLIA) for laboratories: https://www.cdc.gov/clia/index.html